Study Refutes Claims on AIDS Drug Trials

Wednesday

Jan 28, 2009 at 5:23 AM

An investigation has found no evidence that any New York City foster children died as a result of their participation in clinical drug trials for H.I.V. and AIDS.

An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race.

In the late 1980s, as the AIDS epidemic intensified, the city’s child-welfare agency developed a policy to allow foster children to enroll in drug trials at a time when there were no approved treatments for children infected with H.I.V. and AIDS. Hundreds of children received medication in scores of trials conducted from the late 1980s to 2005.

But after charges by a freelance journalist that children were put in trials without their parents’ knowledge and given medications known to cause death, some civil rights activists and City Council members expressed angry concern.

As a result, in 2005 the city commissioned the Vera Institute of Justice, an independent nonprofit group, to investigate the claims. That study, which is to be released on Wednesday, determined that city officials had acted in good faith and in the interests of the children, many of whom were seriously ill.

But it also found that the agency had not always followed its own protocols and kept poor records.

After interviewing dozens of people involved in the trials and reviewing hundreds of thousands of pages of case files, documents and correspondence, the Vera Institute concluded that none of the 532 children in the trials died as a direct result of the medications. (Twenty-five children receiving treatment as part of the trials died during the trial years.)

The report also found that foster children were not removed from their families by the city because a parent had refused to consent to a child’s treatment, as some had alleged.

In addition, the study said that researchers did not specifically select foster children for enrollment in the trials. And while the foster children were overwhelmingly black and Hispanic, as some critics emphasized, that profile mirrored the demographics of children with H.I.V. infection in the city at the time.

“When we read through an amazing volume of material, we found that Children’s Services were aware that this was a very sensitive issue for a lot of important historic reasons,” said Timothy A. Ross, the co-director of the project at Vera.

“Children’s Services did research on the rules and regulations that applied, and developed a reasoned policy in the late 1980s,” he added. “The standard for enrolling kids in foster care that the child welfare agency used was higher than the federal standard.”

However, the institute also discovered problems. “There were clearly breakdowns in the implementation of this policy,” Dr. Ross said.

Sixty-four children participated in 30 medication trials that were not reviewed by a special medical advisory panel, as the city’s policy required. And 21 children participated in trials that the panel had reviewed but had not recommended. (In both cases, 13 of the enrollments occurred before the children were placed in foster care.)

Moreover, the informed consent forms from biological parents or guardians were missing from the child-welfare files in 21 percent of cases, even though regulations and the city’s own policies mandated that they be kept, Mr. Ross said. The state’s Department of Health refused Vera’s request to review medical records, which might have included some additional consents.

“We found a disturbing lack of medical consent forms,” he said. “In some cases we found handwritten consents instead of the official consent forms.” Mr. Ross added that such makeshift permissions violated both city policy and federal regulations.

The commissioner of the Administration for Children’s Services, John B. Mattingly, said in an interview about the report: “In very general terms, it puts to rest the most egregious charges that were being made by a few people three or four years ago. No children were yanked from their homes. That is all completely false.”

Liam Scheff, the journalist in Boston who first made the alarming charges about the trials, questioned that finding.

“Now they admit that the children died, but, oh, it couldn’t have been the drugs,” Mr. Scheff said in an e-mail message. “How do they know? How do they tell the difference?”

He said that the drugs in question had Food and Drug Administration warnings on them and that they had “caused permanent injury and painful death in adults who have taken the exact same drugs at normal prescribed doses. These children died, and countless others were made sick while taking these drugs, because of a diagnosis that is itself overly harsh, overly deterministic” and, he said, based on faulty H.I.V. testing technology.

Mr. Mattingly said the agency had already taken steps to ensure that policies are properly enforced in any future clinical trials involving foster children. Today, no children are involved in medication trials.

One change involved the revamping of the way the agency catalogues and maintains archived case records; an electronic system established in 2004 allows for prompt retrieval of all case files. Another new policy calls for more review by Family Court when a parent is not available to provide consent.

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